Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/12/2009
Date assigned
18/05/2010
Last edited
17/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simon Heller

ORCID ID

Contact details

Professor of Clinical Diabetes
AUDEM Room OU141
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
s.heller@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Does self-monitoring of blood glucose as opposed to urinalysis provide additional benefit to newly diagnosed individuals with Type 2 diabetes receiving structured education?

Acronym

Study hypothesis

To compare the effectiveness of urine and blood glucose monitoring strategies, when taught as part of a structured education programme, on glycaemic control in patients newly diagnosed with Type 2 diabetes. The measure of glycaemic control will be level of HbA1c in the blood 18 months after attending the programme.

Please note, as of 03/11/2011 the anticipated start and end dates have been updated. The previous dates were as follows:
Original start date: 01/12/2009
Original end date: 01/03/2010

Ethics approval

Cambridgeshire 1 Research Ethics Committee approved on the 6th February 2008 (ref: 07/H0304/129)

Study design

Multicentre cluster randomised controlled trial with randomisation at practice level

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format. Please use contact details below to request a patient information sheet

Condition

Type 2 diabetes (newly diagnosed)

Intervention

DESMOND structured group education programme. This is a 7 hour programme (two sessions of 3.5 hours each) which includes a session on self monitoring (blood or urine depending on randomisation of people attending)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c measured at 18 month follow-up

Secondary outcome measures

1. Blood cholesterol
2. Body weight
3. Blood pressure
4. Waist circumference
5. Lifestyle (smoking and physical activity)
6. Questionnaire tools listed below
6.1. Diabetes Treatment Satisfaction Questionnaire
6.2. Well Being Questionnaire - 28
6.3. EQ-5D
6.4. Confidence in Self Care (CIDS)
6.5. Brief Diabetes Perceptions Questionnaire
6.6. Short Form 36 questionnaire
6.7. Summary of Diabetes Self Care Activities

Overall trial start date

28/09/2008

Overall trial end date

21/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. Newly diagnosed and able to attend a DESMOND course within 12 weeks of diagnosis
3. Capable of giving informed consent
4. Primarily responsible for their own care
5. Able to participate in a group programme
6. Can understand both written and spoken English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Severe medical problems (eg severe heart failure, advanced cancer) that would result in the patient gaining no benefit from attending an education programme. This will be at the discretion of the general practitioner.
2. Taking part in another research study

Recruitment start date

28/09/2008

Recruitment end date

21/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Clinical Diabetes
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester (UK)

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom
carolyn.maloney@uhl-tr.nhs.uk

Sponsor type

University/education

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22416896
2014 educators' views in: http://www.ncbi.nlm.nih.gov/pubmed/24405854

Publication citations

  1. Protocol

    Dallosso HM, Eborall HC, Daly H, Martin-Stacey L, Speight J, Realf K, Carey ME, Campbell MJ, Dixon S, Khunti K, Davies MJ, Heller S, Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol., BMC Fam Pract, 2012, 13, 18, doi: 10.1186/1471-2296-13-18.

  2. Eborall HC, Dallosso HM, Daly H, Martin-Stacey L, Heller SR, The face of equipoise--delivering a structured education programme within a randomized controlled trial: qualitative study., Trials, 2014, 15, 15, doi: 10.1186/1745-6215-15-15.

Additional files

Editorial Notes